1.44154

PyroDetect Kit

Reagents and Interleukin-1 ELISAβ kit for Monocyte Activation test (MAT), for Pyrogen testing

• Synonym(s): Pyrogen testing kit
• NACRES: NA.24
• UNSPSC Code: 41116129
• Agency: EP Chapter 2.6.30
• Suitability: pyrogenic bacteria
• Manufacturer/tradename: PyroDetect
• Application(s): pharmaceutical; pyrogen testing
• Storage temp.: 2-8°C

Properties

• agency: EP Chapter 2.6.30
• Quality Segment: 200
• feature: ready-to-use
• packaging: pkg of 1 kit
• manufacturer/tradename: PyroDetect
• application(s): pharmaceutical; pyrogen testing
• compatibility: configured for PyroDetect Systems
• shipped in: ambient
• storage temp.: 2-8°C
• suitability: pyrogenic bacteria

Description

General description

PyroDetect Kit is a Monocyte Activation Test (MAT) for the detection of pyrogens. This test allows the determination of the pyrogenic activity in a solution or suspension by inducing interleukin production in cell cultures with human monocytes.

Application

The PyroDetect Kit is used for the detection and quantification of the pyrogenic activity in pharmaceutical products to ensure their safety.

Biochem/physiol Actions

The PyroDetect System uses cryopreserved human whole blood as a source of monocytes. The response to pyrogenic substances is determined by measurement of the Interleukin-1β (IL-1β) production. The ELISA (enzyme-linked immunosorbent assay) microplate in the PyroDetect System is precoated with an antibody specific for IL-1β. Interleukin molecules present in the culture supernatant, transferred from the blood cultures, are bound to the immobilized antibody.
The unbound substances are washed away, and an enzyme-linked polyclonal antibody specific for IL-1β is added. The IL-1β bound complex is then detected in a color reaction initiated by the addition of a suitable substrate. The efficiency of IL-1β production in the pyrogen reaction is calculated from the data of a photometrical quantification of the colored product by the enzymatic reaction in an ELISA reader.

Features and Benefits

• Ready-to-use kit
• Greater product safety
• Highly compatible
• In vitro test with cryoblood
• Reliable results
• Regulatory recognition

Other Notes

Each PyroDetect Kit contains:

• Cell Culture Microplate for 96 microcultures, with lid - 1 plate
• Cell Culture Medium - RPMI with L-Glutamine and HEPES - 50 mL
• IL-1β Microplate - 12 strips of 8 wells each, coated with a monoclonal antibody specific for IL-1β - 1 plate
• IL-1β Conjugate
• Wash Buffer Concentrate
• Color Reagent Α
• Color Reagent Β
• Stop Solution

PyroDetect Cryoblood (1.44155)
Reference Standard Endotoxin (1.44161)
NEP Control of HKSA (MATHKSA)
NEP Control of Flagellin (MATFLAGELLIN)

Safety Information

• pictograms: GHS05,GHS07
• signalword: Warning
• hcodes: H290 - H317 - H412
• pcodes: P234 - P261 - P272 - P273 - P280 - P302 + P352
• Hazard Classifications: Aquatic Chronic 3 - Met. Corr. 1 - Skin Sens. 1
• Storage Class: 8A - Combustible, corrosive hazardous materials
• wgk: WGK 2